Stable AnginaPhase 4EXPELNCT01899235
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
A Phase 4 study testing drug eluting balloon and drug eluting stent in people with Stable Angina and Coronary Stenosis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Coronary Stenosis
- What is being tested?
- drug eluting balloon and drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- May 2011to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18years old
- Stable angina symptoms
- Elective treatment to coronary lesion
- Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection
Who cannot join
- Left main stem lesion
- Bifurcation lesions
- Acute coronary syndrome (UAP, NSTEMI, STEMI)
- Cardiogenic shock
- Chronic total occlusion
- Additional lesions requiring PCI
Show all 12Show fewer
- Platelet count ≤ 50 x 109/mm3
- Left ventricular ejection fraction ≤ 30%
- Patient life expectancy less than 12 months
- Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
- Participation in another investigational drug or device study
- Patient unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.
- Conditions
- Stable Angina, Coronary Stenosis
- Being tested
- drug eluting balloon, drug eluting stent
- Medical subject headings
- Angina, Stable, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug eluting balloonDevice
drug eluting stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Stent | Active comparator | drug eluting stent (Resolute) Receives: Device: drug eluting stent |
| drug eluting balloon | Experimental | drug eluting balloon (Elutax) Receives: Device: drug eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aachen Resonance GmbH
- Responsible party
- Principal investigator, Svend Eggert Jensen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899235
- Sponsor's protocol ID
- N-20110015
- Acronym
- EXPEL
- Status last verified
- Mar 2014
- First submitted
- 11 Jul 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
- ClinicalTrials.gov ID
- NCT01899235
- Acronym / sponsor ID
- EXPEL / N-20110015
- Conditions
- Stable Angina, Coronary Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aachen Resonance GmbH
- Study start
- May 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Active comparator | Device: drug eluting stentdrug eluting stent (Resolute) |
| drug eluting balloon | Experimental | Device: drug eluting balloondrug eluting balloon (Elutax) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥ 18years old
- Stable angina symptoms
- Elective treatment to coronary lesion
- Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection
Key exclusion criteria (12 listed)
- Left main stem lesion
- Bifurcation lesions
- Acute coronary syndrome (UAP, NSTEMI, STEMI)
- Cardiogenic shock
- Chronic total occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug eluting balloon | Device | drug eluting balloon |
| drug eluting stent | Device | Stent |
Primary outcome
Major adverse cardiac events
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
Related trials for Stable Angina
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing drug eluting balloon and drug eluting stent in people with Stable Angina and Coronary Stenosis, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.